Small Molecule Specific Run Acceptance, Specific Assay Operation, and Chromatographic Run Quality Assessment: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Teams
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- 作者：Eric J. Woolf (1)
Stuart McDougall (2)
Douglas M. Fast (29) (3)
Maristela Andraus (4)
Matthew Barfield (5)
Michael Blackburn (2)
Ben Gordon (6)
David Hoffman (7)
Noriko Inoue (8)
Gabriel Marcelin-Jimenez (9)
Amy Flynn (10)
Richard LeLacheur (11)
Scott Reuschel (12)
Ravisankar Santhanam (13)
Patrick Bennett (14)
Barbara Duncan (15)
Roger Hayes (16)
Berthold Lausecker (17)
Abhishek Sharma (18)
Kazutaka Togashi (19)
Ravi Kumar Trivedi (20)
Miguel Vago (21)
Stephen White (5)
Hollie Barton (14)
John A. Dunn (22)
Raymond H. Farmen (23)
Katja Heinig (24)
Christopher Holliman (25)
Junji Komaba (26)
Maria Francesca Riccio (27)
Elizabeth Thomas (28) - 关键词：bioanalytical assay validation ; LC ; MS/MS ; sample analysis ; small molecule
- 刊名：The AAPS Journal
- 出版年：2014
- 出版时间：September 2014
- 年：2014
- 卷：16
- 期：5
- 页码：885-893
- 全文大小：184 KB
- 参考文献：1. European Medicines Agency. Guideline on bioanalytical method validation 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf. Accessed 26 Jan 2014.
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10. Sennbro CJ, Knutsson M, van Amsterdam P, Timmerman P. Anticoagulant counter ion impact on bioanalytical LC-MS/MS assays: results from discussions and experiments within the European Bioanalysis Forum. Bioanalysis. 2011;3(21):2393鈥?9. CrossRef
11. Sennbro CJ, Knutsson M, Timmerman P, van Amsterdam P. Anticoagulant counter ion impact on bioanalytical LC-MS/MS assay performance: additional validation required? Bioanalysis. 2011;3(21):2389鈥?1. CrossRef
12. World Health Organization. Handbook: good laboratory practice (GLP): quality practices for regulated non-clinical research and development. 2nd ed. Geneva: WHO Special Programme for Research and Training in Tropical Diseases; 2009. 978-92-4-154755-0. - 作者单位：Eric J. Woolf (1)
Stuart McDougall (2)
Douglas M. Fast (29) (3)
Maristela Andraus (4)
Matthew Barfield (5)
Michael Blackburn (2)
Ben Gordon (6)
David Hoffman (7)
Noriko Inoue (8)
Gabriel Marcelin-Jimenez (9)
Amy Flynn (10)
Richard LeLacheur (11)
Scott Reuschel (12)
Ravisankar Santhanam (13)
Patrick Bennett (14)
Barbara Duncan (15)
Roger Hayes (16)
Berthold Lausecker (17)
Abhishek Sharma (18)
Kazutaka Togashi (19)
Ravi Kumar Trivedi (20)
Miguel Vago (21)
Stephen White (5)
Hollie Barton (14)
John A. Dunn (22)
Raymond H. Farmen (23)
Katja Heinig (24)
Christopher Holliman (25)
Junji Komaba (26)
Maria Francesca Riccio (27)
Elizabeth Thomas (28)
1. Merck Research Laboratories, WP 75B-300, West Point, Pennsylvania, 19486, USA
2. Covance Laboratories Ltd, Willowburn Avenue, Alnwick, Northumberland, NE66 2JH, UK
29. Covance Laboratories Inc., MC-11, 3301 Kinsman Blvd., Madison, Wisconsin, 53704, USA
3. Covance Laboratories Inc, Madison, Wisconsin, USA
4. ChromAnalysis, S茫o Paulo, Brazil
5. GlaxoSmithKline, Ware, UK
6. Servier (I.R.I.S), Suresnes-Cedex, France
7. Sanofi, Bridgewater, New Jersey, USA
8. JCL Bioassay, Osaka, Japan
9. Global Bioanalytical Consulting SC, Mexico City, Mexico
10. QPS LLC, Newark, Delaware, USA
11. Agilux Laboratories, Worcester, Massachusetts, USA
12. Tandem Laboratories, Salt Lake City, Utah, USA
13. GVK Biosciences Private Limited, Ahmedabad, India
14. PPD, Richmond, Virginia, USA
15. Duncan Bioanalytical Consultancy LLC, Ledyard, Connecticut, USA
16. MPI Research, Mattawan, Michigan, USA
17. CRS Mannheim, Mannheim, Germany
18. Advinus Therapeutics Ltd, Bangalore, India
19. Sumika Chemical Analysis Service Ltd, Osaka, Japan
20. Syngene International, Bangalore, India
21. Laboratorios Raffo SA, Buenos Aires, Argentina
22. GlaxoSmithKline, Research Triangle Park, North Carolina, USA
23. Celerion, Lincoln, Nebraska, USA
24. F. Hoffman-La Roche AG, Basle, Switzerland
25. Pfizer Inc, Groton, Connecticut, USA
26. Ono Pharmaceutical Co., Ltd, Tsukuba, Ibaraki, Japan
27. CAEP Centro Avan莽ado de Estudos e Pesquisas LTDA, Campinas, S茫o Paulo, Brazil
28. Alderly Analytical Ltd, Cheshire, UK - ISSN：1550-7416
文摘
Consensus practices and regulatory guidance for liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) assays of small molecules are more aligned globally than for any of the other bioanalytical techniques addressed by the Global Bioanalysis Consortium. The three Global Bioanalysis Consortium Harmonization Teams provide recommendations and best practices for areas not yet addressed fully by guidances and consensus for small molecule bioanalysis. Recommendations from all three teams are combined in this report for chromatographic run quality, validation, and sample analysis run acceptance.